| Time | Activity |
|---|---|
| 09:00 - 9:30 | Introduction + Overview |
| 09:30 - 10:30 | SDTM |
| 10:30 - 11:00 | Coffee Break |
| 11:00 - 12:30 | ADaMs with {admiral} and friends |
| 12:30 - 13:30 | Lunch |
| 13:30 - 14:15 | Analysis Results Datasets |
| 14:15 - 15:00 | Create Tables with {tfrmt} |
| 15:00 - 15:30 | Coffee Break |
| 15:30 - 16:15 | Create Tables with {gtsummary} |
| 16:15 - 17:00 | Other Topics Overview + Wrap-up |
End-to-End Submissions in R with the Pharmaverse
Workshop@posit::conf(2025)
🗓️ September 16, 2025 09:00 - 17:00
🏨 Hyatt Regency Atlanta, Room TBA
Description
Ready to optimize your regulatory submission process? This workshop offers a practical, end-to-end introduction to using R for a streamlined workflow from raw data to tables, listings, and graphs (TLGs). We’ll dive into the power of key R packages from the Pharmaverse, starting with SDTM data preparation; learn to effortlessly map, transform, and validate your data to CDISC standards, ensuring both quality and compliance. Next, create ADaM datasets using modular and pipe-able syntax. Finally, get ready to generate compelling TLGs supported by Analysis Results Datasets (ARDs). We’ll explore techniques for producing publication-ready output, customized to meet your specific reporting needs. Walk away with the skills to confidently use R for every stage of the submission process.
Schedule
Pre-work
Instructors
Daniel D. Sjoberg (he/him) is a Senior Principal Data Scientist at Genentech. Previously, he was a Lead Data Science Manager at the Prostate Cancer Clinical Trials Consortium, and a Senior Biostatistician at Memorial Sloan Kettering Cancer Center in New York City. He enjoys R package development, creating many packages available on CRAN, R-Universe, and GitHub. He’s a co-organizer of rainbowR (a community that supports, promotes and connects LGBTQ+ people who code in the R language) and of the R Medicine Conference. His research interests include adaptive methods in clinical trials, precision medicine, and predictive modeling. Daniel is the winner of the 2021 American Statistical Association (ASA) Innovation in Statistical Programming and Analytics award.
Becca Krouse is a data scientist in GSK’s Data Science Innovation and Engineering team where she focuses on enabling users across Biostatistics. A biostatistician by training, she has experience spanning 15 years in the field of clinical research and specializes in developing R-based tools.
Ben Straub is a Principal Programmer at GSK in the Immunology Therapeutic Area since 2018. He has led and helped with many initiatives around R Adoption activities within Clinical Programming since his start at GSK. He is also actively helping to develop and maintain an end-to-end R package pipeline (pharmaverse) that addresses all the needs of Clinical Reporting with many awesome companies and individuals. He is very excited for the future of using R and open source for Clinical Reporting.
Rammprasad Ganapathy (Ram) is a Principal Data Scientist at Roche/Genentech with over 15 years of experience in EDC clinical programming and statistical programming. He leads the OAK team and is the author of the R packages {roak} and its open-source counterpart, {sdtm.oak}. Ram and his team developed the R-based SDTM automation solution, OAK, taking it from a proof of concept to full-scale implementation.